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FDA Study Links Essure Birth Control to Higher Rates of Pain, Bleeding

New data from a study ordered by the U.S. Food and Drug Administration (FDA) suggest that women with the Essure permanent birth control implant face higher rates of pain and bleeding compared to women without the device.

The new findings come from a recently published postmarket surveillance study into the long-term safety of Bayer’s Essure birth control device, which was taken off the U.S. market in December 2018 after thousands of women reported adverse side effects and serious complications.

An FDA press release from July 8, 2020 details the agency’s efforts to better understand complications women with Essure may experience. According to early overall results, researchers found Essure patients, when compared to women who underwent tubal ligation as their permanent birth control, tend to have higher rates of:

  • Chronic lower abdominal and / or pelvic pain;
  • Abnormal uterine bleeding; and
  • Gynecologic surgery, including surgical removal of Essure.

The FDA reported that it will work with Bayer to release an additional analysis at the 1-year mark following a patient’s Essure implantation, which is earlier than the previously planned 3-year analysis.

The agency continues recommend that women using Essure successfully to prevent pregnancy can and should continue to do so, and that women who suspect the device may be causing pain, bleeding, or other related symptoms speak with their doctors, as device removal can pose risks.

Essure Birth Control: A History of Safety Concerns

Since its approval in 2002, Bayer’s Essure permanent birth control has been the subject of numerous complaints from women across the country, many of whom have reported adverse side effects after having the device implanted, as well as the need for risky removal procedures.

Some of the most serious side effects associated with Essure include:

  • Perforation of the uterus, fallopian tubes, and other pelvic organs
  • Expulsion and infection
  • Abnormal bleeding
  • Chronic and severe pain
  • Device breakage, displacement, and migration
  • Allergic reactions (nickel) and autoimmune disease
  • Headaches, migraines, fatigue, and vision impairment
  • Interstitial cystitis

Over the past several years, health agencies and watchdogs have taken a number of actions to monitor the safety of Essure and inform women with the device about potential risks. In February, researchers at the National Center for Biotechnology Information (NCBI) suggested that Essure be removed in all symptomatic women. Previous studies have also showed that women with Essure face increased risks of repeat procedures, and that women who undergo Essure removal procedures face numerous risks, potential complications, and physical, financial, and emotional repercussions.

BCH: Fighting For Victims of Medical Device Injuries

Bailey Cowan Heckaman PLLC has been closely following safety concerns, studies, and FDA oversight of Essure for several years, and has made our team available to women and families who’ve suffered losses as a result of the implant in their fight for justice and compensation.

As a firm nationally recognized for our work in complex and high-profile claims – including those involving defective drugs and medical devices – BCH is here to help anyone who would like to learn more about their rights and legal options after experiencing side effects and complications involving Essure.

To request a FREE evaluation of your case, call us or contact us online. Based in Houston, BCH proudly serves victims and families nationwide.

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